Biomarkers of Dietary Intake and Exposure Data Coordinating Center
Biomarkers of Dietary Intake and Exposure Data Coordinating Center
批准号:
10286935
负责人:
Hrishikesh Chakraborty
金额:
$56.35万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
未结题
起止时间:
2021-08-16 至 2026-06-30
关键词:
AddressAncillary StudyBiological MarkersBiomarker of Dietary IntakeBiometryCertificationClinical ResearchClinical Trials Data Monitoring CommitteesCollaborationsCommon CoreCommunicationCommunitiesComplementConfidentiality of Patient InformationCongressesConsensusConsent FormsDataData AggregationData AnalysesData CollectionData Coordinating CenterData FilesData SetDevelopmentDietary AdministrationDietary intakeDocumentationEnrollmentEnsureFoodGoalsGuidelinesHealth Insurance Portability and Accountability ActIndividualInfrastructureInstitutesInstitutional Review BoardsKnowledgeLeadershipLinkLogisticsManualsManuscriptsMetabolicMetabolismMethodologyMethodsMonitorNational Institute of Diabetes and Digestive and Kidney DiseasesNatureOffice of Administrative ManagementOnline SystemsOutcomePerformancePositioning AttributePreparationPrivacyProductivityProtocols documentationPublicationsReportingResearchResearch InstituteResearch Project GrantsResourcesRiskSafetyScienceSecureServicesSiteStandardizationStatistical Data InterpretationStructureTeleconferencesTimeLineTrainingUnited States Department of AgricultureVisionVisualWorkWritingbiomarker developmentbiomarker performancebiomarker validationcatalystcloud storagedata anonymizationdata disseminationdata exchangedata harmonizationdata integrationdata managementdata modelingdata qualitydata repositorydata sharingdata submissiondietarydietary constituentelectronic data capture systemevidence baseexperienceimprovedinnovationmeetingsmembermicrobialmultidisciplinaryoperationrecruitrepositorytooltransmission processuser-friendlywebinarworking group
中文摘要
项目概要/摘要
膳食生物标志物开发中心 (DBDC) 联盟的目的是确定
膳食摄入的生物标志物可以作为膳食摄入的独立标志物
补充当前的膳食摄入评估方法和不断发展的证据
解决膳食成分(尤其是非膳食成分)代谢转化的基础
宿主和微生物代谢产生的营养物质。数据协调中心 (DCC) 的目标是:1)
提供健全的行政管理结构,加强沟通和
协作并提高 DBDC 联盟的生产力和质量,2) 提供数据
传输、协调、集成、处理和管理,3) 开发自助服务
分析平台和交互式报告,供用户进行分析,4) 沟通
并在联盟内部和外部传播知识。在操作上,DCC 将
制定操作手册,提供协议培训,建立和监控时间表,
与指导委员会 (SC)、NIDDK/USDA 以及数据安全和
监控委员会(DSMB)。对于数据管理,DCC 将建立符合联邦标准的
在线电子数据采集系统,支持直接提交数据和基于网络的
用于安全数据共享和协作的联盟通信和协作平台(CCCP)
传播工具和结果。 CCCP 将有一个访问自助服务的链接
分析和交互式报告,以方便轻松访问数据。 DCC 将定期
评估数据质量,检查数据完整性,开发数据文档,
确保保护患者机密,为 SC 和 DSMB 准备报告,并准备
去识别化的公共使用数据文件提交到 NIDDK 存储库。最后,DCC 将
提供思想领导、生物统计支持和方法创新来解释
膳食生物标志物开发的多方面性质,并促进制备和
通过多份高影响力的手稿和演示文稿传播研究结果。我们的
团队在数据管理、统一和协调方面拥有全国公认的专业知识
大型网络,以及我们在生物标志物研究方面的经验,使 DCRI 能够
提供联盟所需的所有服务和支持。
英文摘要
Project Summary/Abstract
The purpose of the Dietary Biomarker Development Centers (DBDCs) Consortium is to identify
biomarkers of dietary intake that can serve as independent markers of dietary intake and
complement current dietary intake assessment methods and the continually evolving evidence
base for addressing metabolic transformation of dietary constituents, especially the non-
nutrients by host and microbial metabolism. The Data Coordinating Center (DCC) aims to: 1)
provide a robust administrative management structure that enhances communication and
collaboration and improves the DBDC’s Consortium productivity and quality, 2) provide data
transfers, harmonization, integration, processing, and management, 3) develop a self-service
analytics platform and interactive reporting for users and conduct analyses, and 4) communicate
and disseminate knowledge within and beyond the Consortium. Operationally, the DCC will
develop manuals of operations, provide protocol training, establish and monitor timelines,
organize meetings with the Steering Committee (SC), NIDDK/USDA, and Data Safety and
Monitoring Board (DSMB). For data management, the DCC will establish a federally-compliant
online electronic data capture system to support the direct submission of data and a web-based
consortium communication and collaboration platform (CCCP) for secure data sharing and
dissemination of tools and results. The CCCP will have a link to access the self-service
analytics and interactive reporting to facilitate easy access to the data. The DCC will periodically
assess data quality, perform checks for data completeness, develop data documentation,
ensure protection of patient confidentiality, prepare reports for the SC and DSMB, and prepare
de-identified public use data files for submission into the NIDDK repository. Finally, the DCC will
provide thought leadership, biostatistical support, and methodological innovation to account for
the multi-faceted nature of dietary biomarker development, and facilitate the preparation and
dissemination of study results through multiple high-impact manuscripts and presentations. Our
team’s nationally recognized expertise in data management, harmonization, and coordination of
large networks, and our experience in biomarker research uniquely positions the DCRI to
provide all of the services and support required by the Consortium.
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会议论文
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